1. Scrip
  2. >>R&D

Real World Data Adoption About 10% Amid Challenges: Parexel Executive

Innovation Hub Set Up In India

 
• By Vibha Ravi

While real world data is reliable, synchronization challenges limit its use, Sanjay Vyas, executive vice president and managing director Parexel India tells Scrip in a wide-ranging interview that touches on aspects from synthetic analytics to the interest among Indian companies in developing cell and gene therapies

Clinical Research Vector
Clinical Research Is Evolving With Real-World, Synthetic Data • Source: Shutterstock

Real world data has been gaining credence among regulators for decisions on drug approval and label expansion given that randomized clinical trials take place in controlled environments in a well-defined population that might also not be truly representative of ethnic or gender diversity.

After the US Food and Drug Administration (FDA) made its first label expansion based on real world evidence in 2019 for Pfizer Inc.’s Ibrance (palbociclib), it turned into a credible alternative to the gold standard of randomized clinical trials. Similarly, clinical-stage company Medicenna Therapeutics Corp

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from R&D

More from Scrip

Novo Nordisk’s CEO Forced Out After Falling Behind In GLP-1 Battle

 
• By Andrew McConaghie

Company surprises investors with Jørgensen's exit but insists its strategy will not change.

In Brief: US FDA Delay Sends Biohaven Shares Down

 
• By Andrew McConaghie

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Executives On The Move: Pathos Procures CEO From AstraZeneca, New CEO For TME Pharma, And More

Recent moves in the industry include changes at the top at Akamis Bio, Innospera Pharma & Ispen, plus Astellas Korea appoints an ex-Novartis Korea executive.